ANTISEPTIC- alcohol, lidocaine hydrochloride liquid

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Antiseptic towelette

Drug Facts

Active Ingredients

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

First aid to help prevent infection in minor scrapes and temporary relief of itching of insect bites

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

• over large areas of the body
• in eyes
• over raw or blistered areas

Stop use and ask doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Directions

• adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.
• children under 2 years of age: Consult a doctor.

Inactive ingredients benzalkonium chloride, menthol, purified water

PRINCIPAL DISPLAY PANEL – mini pouch label

Safetec

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com

EXP. LOT

PRINCIPAL DISPLAY PANEL – 150 count box

Safetec

NDC: 61010-5200-4

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

Reorder No.
52004

Contents: 150 single-use, premoistened towelettes

PRINCIPAL DISPLAY PANEL – 2 fl. oz. bottle

NDC: 61010-5200-1

Safetec

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

2 fl. oz. (59.1 ml)

Reorder No.
52001
Package Not Child Resistant

Principal Display Panel – 25 Count Box Label

NDC: 61010-5200-7

Safetec

Sting Relief

Insect Bite

Antiseptic and Pain Reliever

Contents: 25 single-use, premoistened towelettes

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
alcohol, lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-5200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	500 mg  in 1 g
lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride (UNII: F5UM2KM3W7)
menthol, unspecified form (UNII: L7T10EIP3A)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-5200-1	56.0 g in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2011
2	NDC: 61010-5200-4	150 in 1 BOX	09/30/2011
2	NDC: 61010-5200-3	0.8 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 61010-5200-5	10 in 1 BOX	09/30/2011
3	NDC: 61010-5200-3	0.8 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 61010-5200-2	100 in 1 BOX	09/30/2011
4		1.8 g in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 61010-5200-6	20 in 1 BOX	09/30/2011
5		1.8 g in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 61010-5200-7	25 in 1 BOX	09/30/2011
6		1.8 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/30/2011

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-5200)